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OpenTrials
Completed

NCT Number: NCT07511075

Impact of Implementing Reach Out and Read in the Neonatal Intensive Care Unit

This is a pre/post quasi-interventional study with two arms. First, a baseline cohort of parent-infant dyads admitted to the Neonatal Intensive Care Unit (NICU) were enrolled and surveyed at three timepoints (admission, discharge, and one-month post-discharge) to characterize baseline habits, attitudes, and barriers toward shared reading in the NICU in the absence of a shared reading program. Reach Out and Read (ROR) in the NICU, a shared reading program modified from the national ROR outpatient program to the NICU setting was then implemented. Following program implementation, a subsequent cohort of parent-infant dyads admitted to the NICU were enrolled (the "ROR" cohort) and surveyed at the same three timepoints. Feasibility, acceptability, and preliminary efficacy of ROR NICU to promote shared reading in the NICU were evaluated.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Parent-infant dyads were recruited with the following criteria:

Inclusion criteria

  • New neonatal admission to the NICU at less than or equal to 14 days old
  • Estimated length of stay 2 weeks or longer
  • English or Spanish speaking

Exclusion criteria

  • Nonviable neonates or those with uncertain viability
  • Families with discontinuous social situations or parent/infant separation

Treatment and study plan

Shared reading program

Other

Reach Out and Read in the NICU (ROR NICU) was implemented. All infants admitted to the NICU receive a book paired with education/anticipatory guidance on shared reading every two weeks during their NICU admission.

Primary outcomes

  1. Rate of regular reading

    Time frame: Time point 1: baseline. Time point 2: average 6 weeks after baseline. Time point 3: 4 weeks after time point 2

    Parent-reported frequency of shared reading (days/week) in the last week with "regular reading" defined as at least 3 times per week.

Secondary outcomes

  1. Proportion of eligible infants who received the intervention

    Time frame: After infant discharge, average of 6 weeks from baseline.

    This is a program fidelity measure assessing how many infants admitted to and discharged from the NICU received the intervention (defined as receiving a book paired with education about shared reading)

  2. Program acceptability

    Time frame: Time point 1: baseline. Time point 2: average 6 weeks after baseline. Time point 3: 4 weeks after time point 2

    Survey questions exploring parent experience of the program and an "Acceptability of Intervention Measure" 4-item scaled score (likert scale 1-5) from Weiner et al 2017.

  3. Frequency of intervention per patient (fidelity to the model)

    Time frame: After infant discharge, average of 6 weeks from baseline

    The frequency and timing of when each ROR cohort infant received a book during admission was tracked

Sponsors and collaborators

Lead sponsor

Catherine Caruso

Other

Collaborators

  • Academic Pediatric Association

Registry information

Official study title

Developmental Promotion in the Neonatal Intensive Care Unit; A New Shared Reading Program

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 6, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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